Omthera Pharmaceuticals, a privately-held New Jersey-based specialty pharmaceuticals company, said the first patient has been dosed in its pivotal phase III EVOLVE (EpanoVa fOr Lowering Very high triglyceridEs) trial for Epanova, the company's lead compound for the treatment of patients with very high triglycerides. Epanova is an Omega-3 fatty acid containing a novel formulation of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). The phase III trial was granted a Special Protocol Assessment (SPA) from the FDA.
The phase III EVOLVE trial is a 12-week multi-center, randomized, double-blind, placebo-controlled study that will evaluate the efficacy and safety of three doses of Epanova in patients with fasting triglyceride (TG) levels of greater than or equal to 500 mg/dL. The trial, which will be the largest of its kind conducted in this patient population to date, is expected to enroll approximately 330 patients and is being conducted in 60 centers throughout North America, Europe and India. Subjects will be randomized into four groups as follows: (1) Epanova 2g/day; (2) Epanova 3g/day; (3) Epanova 4g/day; or (4) placebo 4 caps/day. The primary endpoint is the percentage change in triglyceride level from baseline to week 12. The secondary endpoint is the reduction of non-HDL cholesterol.
Triglyceride lowering with Epanova was previously observed in two large, placebo-controlled, randomized, double-blind, Phase III studies involving 748 Crohn's disease patients with normal triglyceride levels for greater than or equal to 52 weeks, approximately 400 of which were treated with Epanova for remission of disease. In all studies performed to date, Epanova has demonstrated a very good safety and tolerability profile.